REACH—The Essential Guide

Posted: June 16, 2008

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The new regulation aims to generate data on the effects of chemical substances so that they may be used safely. Manufacturers and importers who place chemicals on the market will now be responsible for understanding and managing the risks associated with their use. This should result in a more innovative and competitive European chemical industry that also encourages the substitution of toxic chemicals with safer alternatives.

The key element of the REACH regulation is the requirement for manufacturers or importers of chemicals to register them with the European Chemicals Agency (ECHA). A registration dossier will be supported by a standard data set on that substance. However, the data requirement for each substance will be dependent on the amount that is manufactured or supplied and the toxicity of the substance. So, the largest volume and most toxic substances will require the most data for their registration dossiers. If chemicals are not pre-registered and then registered, the substance will not be able to be sold.

Breadth of REACH

It cannot be denied that REACH regulation is extremely complex. A huge number of substances used in the flavor and fragrance industry will be affected by the new regulation. These include fragrance ingredients (e.g., aroma chemicals, essential oils and natural extracts), flavors in oral care products (e.g., mint oils), flavors in tobacco and isolated intermediates. There are some exclusions such as substances deemed generally safe (e.g., water, corn oil), preparations (mixtures of substances/blends), flavor and food ingredients and additives, pharmaceutical ingredients and non-isolated intermediates. Essential oils and natural extracts are only included if they are used as flavor or fragrance ingredients in cosmetics.